FDA reveals restricted use of Novartis' Zelnorm

The FDA has permitted the restricted use of constipation-predominant IBS drug Zelnorm (tegaserod) under a treatment investigational new drug protocol.

The ruling also includes the treatment of chronic idiopathic constipation (CIC) in women younger under 55 years of age who meet specific guidelines. Zelnorm will remain off the market for general use.

Patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available. These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug.

In FY06, Zelnorm sales were USD 561m, of which US sales accounted for USD 488m. Novartis revised its FY07 local currency sales growth outlook as a result and said it expected sales to grow above five percent. The company continues to stress that no causal relationship exists between ischemic CV events and tegaserod.